Episode 6 - Regulatory Science
This episode's guests: Dr. Joe Lennerz
Our guest this week is Dr. Joe Lennerz, Associate Chief of Pathology and the Medical Director of the Center for Integrated Diagnostics (CID) at Massachusetts General Hospital (MGH). He oversees all aspects of the clinical laboratory service that supports personalized medicine at MGH.
He was the principal investigator of the first FDA instrument precision study for the first whole slide scanning system.
We're talking about Regulatory matters in digital pathology, the various regulatory bodies at play and the alphabet soup of regulation such as CLIA, CAP , FDA, GDPR and so forth.
We'll discover what is the 21st Century Cures Act and how does it impact digital pathology? And many folks may be surprised to learn about new initiatives such as the Digital Health Center of Excellence at the FDA designed to spur innovation.
We’ll learn about the Alliance for Digital Pathology - A regulatory science initiative to harmonize and standardize digital pathology processes to speed up innovation to patients.
In the past, it's been tempting for many of us to think of regulation as a burden but is this mode of thinking outdated? By proactively forming partnerships with regulatory bodies, will we actually be able to spur innovation and advance the state of the Science?
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More About Dr. Joe Lennerz
Dr. Joe Lennerz is the Associate Chief of Pathology and the Medical Director of the Center for Integrated Diagnostics (CID) at Massachusetts General Hospital (MGH).
He oversees all aspects of the clinical laboratory service that supports personalized medicine at MGH. The main aim of the CID is to improve patient outcomes by optimizing care delivery through rapid clinical integration of innovative technologies. Dr. Lennerz is board certified by the American Board of Pathology and the American Board of Medical Genetics. He completed his residency training in anatomic pathology in 2008, and a fellowship in molecular genetic pathology in 2009 at Washington University in St. Louis, MO. He was the principle investigator of the first FDA instrument precision study for the first whole slide scanning system and his interests are tissue-based biomarkers, and financial sustainability of molecular genetic diagnostics. In his free time, he loves playing at open mics.